‘Marketplace’ (American Public Media) takes a look at what some states are doing to combat pharmaceutical sales reps influence on prescribing, and help get doctors the best evidence–without the sales pitch.

‘Marketplace’ followed “academic detailers” employed by the state of Pennsylvania as they visit with physicians. Tom Snedden, the director of the program, which employs 11 academic detailers–often nurses or pharmacists–said the program was small but effective in improving quality and reducing unnecessary costs.

“The industry’s trying to sell a product. What we’re trying to sell is clinically-appropriate prescribing,” he said. “Since the program began in 2005, the doctors who have met with academic detailers have prescribed fewer brand name drugs and fewer drugs overall.”

Other states have taken their cue from Pennsylvania since it implemented it’s academic detailing program 5 years ago. Three New England states are sharing best practices and resources in a regional academic detailing initiative. Legislation has passed in four states and D.C., while three additional programs were implemented by state Medicaid agencies.

This session in Wisconsin, Rep. Chuck Benedict has introduced an academic detailing bill, which is backed by the broad group of supporters, led by the Coalition of Wisconsin Aging Groups. The bill will be heard in a joint public hearing on prescription drug reform in March.

And in Minnesota, academic detailing legislation is being considered as part of a prescription reform package. The bill (Sen. Sheran) backed by the newly-formed Minnesota Prescription Coalition, has cleared two key committees in the Senate and is now before the Finance Committee; a House counterpart (Rep. Liebling) is due to be heard by the House Health Policy Committee in early March. (More information at the coalition website)

Because of the success of such programs at the state level, development of a federal prescriber education program is underway.

Wisconsin Sen. Herb Kohl, Chair of the Congressional Special Committee on Aging, sponsored the federal Independent Drug Education and Outreach Act of 2009.

And the Obama administration and Agency for Healthcare Research and Quality have demonstrated support for this approach, too, including academic detailing as an example of an intervention to promote the adaptation and dissemination of comparative effectiveness research products in a request for proposals the Agency posted in September, 2009—a new round of AHRQ grants was announced last week as well.

Listen to the full Marketplace story, or learn more about prescriber education at Prescription Access and Quality and the Pew Prescription Project.

–Kate Petersen, PostScript blogger

In his health care reform proposal to Congress and the nation revealed today, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

Here’s the language:

To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

The President’s health care reform proposal also requires pharmacy benefit managers to disclose information about negotations and drug pricing deals they make, a component of the original House bill passed in November.

President Obama’s proposal goes beyond the Senate bill on prescription drugs in two other important ways:  closing the Medicare Part-D ‘doughnut hole,’ and banning pay-for-delay settlements that keep drug costs artificially high.

By closing the doughnut hole, the President’s plan would save the 8 million seniors who exhaust their prescription drug benefits each year an average of $4,080 a year by 2020. Like today, seniors will still have a 25 percent co-insurance obligation until ‘catastrophic’ coverage kicks in, unless they qualify for low-income subsidized coverage.

The proposal also grants the Federal Trade Commission the authority to police drug company patent settlements for “collusion” to keep generics off the market. FTC estimated that such a reform would save $35 billion over the next decade, and Obama’s proposal would give FTC the authority to prevent these settlements unless proven to increase competition.

–Kate Petersen, PostScript blogger

In her testimony before the House Energy and Commerce committee on health appropriations, HHS Secretary Kathleen Sebelius called for $101 million of FDA’s 2011 budget request to be used for a “medical product safety initiative” to increase inspections and “invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products.”

We are glad to see the Secretary recognizing the need for increased inspections –  the lack of foreign inspections is a  problem highlighted recently by FDA itself and the GAO, which found that FDA is able to inspect just seven percent of prioritized foreign drug manufacturing sites every year. This, despite evidence that foreign India and China alone produced close to 70 percent of the global supply of active drug ingredients in 2007 – up from just under half of the APIs three years before.

Doing the math, that means plants making U.S drugs overseas may wait well over 10 years between FDA inspections, while domestic plants are inspected every 2.7 years on average.   The rate of inspection within China is even lower. If unchanged, it would take nearly 50 years to inspect all 700 or so FDA-registered Chinese drug-manufacturing sites.

Recent increases in budget appropriations for FDA have allowed the agency to begin to build its foreign inspections program, as well address structural problems at the agency like understaffing and IT capacity.  But serious structural problems affecting the agency’s ability to regulate drug manufacturing and importation remain.  And considering the growth rate of foreign manufacturing plants and how thinly resources must be stretched.  The increased appropriations the Secretary recommends will likely still be insufficient to bring foreign inspection up to speed with domestic inspection rates.

One way to help correct for this would be to consider a user fee system as proposed in legislation introduced in both the House and Senate in the current Congress. The agency already employs user fees with drug manufacturers during the approval process, and with food and drug companies whose manufacturing violations require re-inspection. A similar user fee for general Good Manufacturing Practice (GMP) inspections inspections would help protect consumers.

Inspections alone are not the solution. FDA must find better ways to predict risk. And the agency is taking steps. For example, at the border, the agency uses  PREDICT, a new web-based risk-based assessment system that incorporates inspection histories, counterfeit risk, and environmental influences. But such a system could also be used earlier in the inspection process, to target overseas manufacturing inspections before risky products ever get shipped or unloaded at the docks.

–Kate Petersen, PostScript blogger

As Cephalon joins the ranks of pharmas disclosing payments to physicians or health care entities under corporate integrity agreements, John Mack at the Pharma Marketing Blog and Eric Milgram over at Pharma Conduct have good posts on the importance of the format in which companies have posted data about who’s getting what.

In a distinction Mack describes as translucent vs. transparent, Cephalon’s payments are posted in FlashPaper, a format that does not allow the data to be copied and is hard to search. So are Eli Lilly’s, which began disclosing under a similar agreement late last year. Merck and GlaxoSmithKline, who began disclosing some payments (these were not court-ordered disclosures) last month, publish the data in PDFs, which are unsortable and hard to search, but at least allow data to be extracted.

All the companies fall short in that they provide little or no additional detail on the nature or purpose of the payments. Merck only reports payments to U.S.-based health care professionals who speak on behalf of Merck or its products through Merck Medical Forums, presumably excluding payments to providers who provide other types of services.  And no companies have provided complete disclosures that include all those paid for clinical trials and every type of research, although GSK plans to begin reporting compensation to research investigators in 2011.

Eric Milgram’s checklist for what details make disclosure data usable and valuable to the public is a great place to start. He says at minimum, disclosure data should include a provider’s name, specialty, main hospital or practice affiliation, and a brief description of the reason for payment.  And he says that companies shouldn’t only have to disclose those payments made to physicians, but to all health care providers.

The lesson in all this? When it comes to disclosure, details matter. The program Cephalon and Lilly have used to date make searching difficult and copying impossible. There are easier programs out there: it’s time to use them. Without useful markers—(it’s not as helpful to search for a doctor by the letters in her name if you can’t also search by state, specialty, or practice location)–it’s difficult for consumers and researchers to use the data to make informed decisions or analyze trends in industry-physician relations—arguably the very reason such disclosures are part of court settlements.

These first disclosure attempts provide good lessons for courts that wish to make meaningful disclosure a part of future settlements, as well as state and federal regulators who are developing or may have to plan for uniform disclosure databases such as those proposed in the Physician Payment Sunshine provisions and bills being introduced in several states this year.

As a postscript, it’s worth remembering that despite the good publicity some pharmas have gotten for putting this data on their websites “voluntarily” (see: Eli Lilly), half of the companies that have disclosed payments so far (and more than half, if you count medical device companies) have done so by order of a court because they settled on charges of systematic inappropriate marketing – cases that have yielded enlightening documents about company marketing practices and their sway over company research, authorship, and publication.

–Kate Petersen, PostScript blogger

-by Michele Kimball, state director, AARP Minnesota

At the Minnesota State Capitol today, lawmakers are hearing about important proposals to reform the way prescription drugs are prescribed in Minnesota.  AARP is pleased to be part of the Minnesota Prescription Coalition working to help this effort gain the attention it deserves  — and to ultimately pass these important reforms.

Why do we care?
AARP represents about 700,000 consumers in Minnesota over the age of 50.  It comes as no surprise that older Minnesotans have a huge stake in this game because they are the biggest consumers of prescription drugs.

Prices of drugs continue to rise, having a direct negative effect on older and disabled Americans, especially those on fixed incomes. These are the Minnesotans who won’t receive a Social Security cost-of-living increase in 2010 because of low inflation of nearly every other sector of the economy.

Higher drug prices mean that Minnesotans enrolled in Medicare’s Part D drug program more quickly reach the “doughnut hole”—the coverage gap in which they must currently pay the full price of their medications.  To be sure, older consumers want policymakers to do whatever they can to control costs.

But it’s not just about drug costs.  It’s about quality, ethical health care – and about ensuring that our loved ones get the right drug and the right information whenever they visit a doctor.

Kim Witczak’s Story
No one can speak to this issue better than Kim Witczak, a very brave consumer from Minneapolis who has become an expert on prescription drug issues since the death of her husband.

On August 6, 2003, Kim’s husband, Woody died of a Zoloft-induced suicide at age 37. He was not depressed, nor did he have any history of depression or any other mental illness. He died after taking the drug a total of 5 weeks with the dosage being doubled shortly before his death. He was given the antidepressant from his general physician for “insomnia.”

Kim told Minnesota’s lawmakers that Woody loved life. He was a compassionate, loyal husband, son, brother, uncle, godfather and friend. He had endless energy, a constant smile and a laugh that could be heard a mile away. Woody had a successful sales career and had just started his dream job as VP of sales with a start up company. He was excited about this new opportunity and along with this excitement came difficulty sleeping. He went to see his family doctor and after a 5-minute consultation, he was given Zoloft for an insomnia diagnosis.  This was the first time he’d ever gone to a doctor for this sort of issue.   Read more about his story at www.woodymatters.com.

Kim talked about the current way we prescribe drugs and how Woody and his doctor became victims of a system that is too focused on marketing and profits.  Woody was given a 3-week sample of Zoloft by his general practitioner.  Insomnia is an “off-label” use for Zoloft.  Samples are a marketing technique used to promote drugs.

Marketing and Detailing

Too much of the information and research that doctors get about the drugs they prescribe comes from the drug companies’ representatives.  As Allan Coukell of the Pew Prescription Project testified today, spending on marketing and promotional goods by the pharmaceutical industry is estimated at nearly $30 billion – much of it directed at those who prescribe medications.  Drug reps visit the office to discuss the attributes of the drugs and to leave samples.  In fact, between 60-80 percent of all antidepressant prescriptions are written after about a 5-10 minute consultation by general practice or family doctors who may or may not know the significance of all the side effects.

From a consumer’s perspective, educating doctors about new drugs should not be left to marketers.  Doctors need nonbiased information and they need all the research available to know the risks of what they are prescribing.  Patients need to know that their health care providers are delivering the best care possible and that they are not swayed by gifts or other financial incentives.

Marketing and sales practices have no doubt compromised the doctor-patient relationship and have contributed to the skyrocketing costs of prescription drugs and the overall increase in health care costs.

So What Happened Today?
The Minnesota Prescription Coalition and key legislative authors presented three bills today to help reduce the current conflicts or interest between pharmaceutical industry and doctors.

• Legislation that will prohibit pharmaceutical companies from buying doctors’ prescribing records and using the information to target their marketing to individual doctors. Pharmaceutical Data Mining: S.F. 1044 (Sen. John Doll) and H.F. 491 (Rep. Tina Liebling)

• Legislation that will ban gifts to providers from pharmaceutical manufacturers and improve transparency and reporting laws that more clearly define relationships between health care providers and pharmaceutical companies. Pharmaceutical and Medical Device Gift Ban:  S.F. 1237 (Sen. John Marty) and H.F. 1641(Rep. Tina Liebling)

• Legislation to establish an “academic detailing” program to give physicians nonbiased information to make the best and most cost-effective decisions about prescriptions. Independent Prescriber Education Program “Academic Detailing” S.F. 895 (Sen. Kathy Sheran) and H.F. 1640 (Rep. Tina Liebling)

I believe that momentum is growing in Minnesota among consumers, providers and policy experts to establish objective, evidence-based methods of getting accurate information into the hands of physicians and other prescribers.

Dr. Chris McCoy, a physician in Rochester, and policy chair of the National Physicians Alliance spoke about how many doctors feel about the current marketing practices of pharmaceutical companies.  “Trust in the medical profession is slipping away as pharmaceutical companies buy influence through our systems,” said McCoy.  “Families and patients need to trust that doctors are making the best decisions, based on nonbiased information.”

I can tell you from my experience in conversations with AARP members here in Minnesota, frustration about the negative effects of the pharmaceutical industry’s marketing practices is at an all-time high.

We still have a lot of work to do.  The opposition to this legislation is out in force.  I believe that eventually, these bills will prevail.  Minnesotans are a very common-sense lot.  These bills make common sense for consumers, health care providers, insurers and government entities in Minnesota.

Yesterday, the FDA unveiled ‘FDA Basics’, a website tool geared to help the public get to know the FDA staff and what they do. The website will provide explainers to questions about what the agency and its different centers do, videos and profiles of agency leaders, as well as hosted online conversations between FDA officials and the public.

FDA Basics is the first of a three-part transparency initiative that the agency is undertaking under the Obama administration.  In a webinar Tuesday, deputy commissioner Joshua Sharfstein said the Basics site grew out of unsolicited public feedback to the transparency task force seeking more info about how the agency works.

But the site won’t offer the clinical safety and efficacy information on specific drugs that many consumer advocates have called for. That, Sharfstein said, is part of daunting phase two, in which the agency will make recommendations about what information should be made public and accessible  and how — including clinical trials information, recalls, approval and warning letters, and post-market surveillance.  Recent reports (see our blog last week) have highlighted the unavailability of this information to prescribers and the public–even about some of the top-prescribed drugs in the U.S.

Phase three will establish how the agency interacts transparently with regulated industries.

Sharfstein commended the tremendous feedback the agency received on the FDA transparency blog and at the task force’s public hearings, and invited more on the FDA Basics website. In response to a webinar question, he also said that the site should provide information about how to become an advisory committee member for the agency.

Check out FDA Basics here.

–Kate Petersen, PostScript blogger

A review by the Sunlight Foundation found that important safety and other clinical data on more than one-third of the top-prescribed drugs in the U.S. is  not readily available to prescribers, researchers and patients. The transparency watchdog group found that nine of the 25 top-prescribed drugs, including Lipitor, Effexor, and Plavix, lack this online information–meaning most prescribers have an incomplete picture of safety and efficacy on commonly-written scrips.

The data, required by the FDA for approval but often left unpublished in medical journals and other venues, is only online for drugs approved after 1998. Even then, Sunlight reports, the online info may be heavily redacted and is published in manually-created PDFs that “are not hyper-linked or text searchable, and therefore are hard to navigate.” Information on drugs approved before 1998 has to be obtained by the characteristically slow and cumbersome Freedom of Information Act request, a process most physicians don’t use to inform prescribing decisions.

The Foundation says its unclear whether such data will be included as part of the Obama administration’s Open Government Directive, a plan to have each government agency publish previously undisclosed data sets to the public, but drug safety advocates like Dr. Steven Nissen of the Cleveland Clinic say that such drug info should “absolutely” be included.

For more on the review, including a list of the top-prescribed drugs and which data remains inaccessible, read the story here.

–Kate Petersen, PostScript blogger

In a look both back and ahead at the relationships between the pharmaceutical and medical device industry and physicians, Modern Healthcare reports today that transparency has come a long way in the last three years, but there’s still a ways to go to “ensure patient care is free of financially induced bias.”

When the Senate began investigating the issue of payments from pharma and medical device companies to physicians three years ago, many in the industry denied there was a problem, writes Modern Healthcare.  “But now the healthcare industry appears poised, even if reluctant, to remove the veil that has cloaked industry-provider financial ties. An increasing number of provider organizations, medical-device companies and drugmakers have begun voluntarily disclosing those relationships, and the proposed Physician Payments Sunshine Act, which would mandate disclosure, may soon become law as part of Congress’ healthcare overhaul.”

Indeed, major drugmakers like GlaxoSmithKline and the medical device trade organization AdvaMed actively support the Senate bill, which is moving through the health care reform process now. And a number of companies, including GSK, have pledged to voluntarily disclose payments made to physicians and medical groups.

The Pew Prescription Project’s Allan Coukell and other supporters of the Physician Payments Sunshine provisions say that such voluntary disclosure efforts are no stand-in for a uniform and comprehensive transparency law like the Sunshine proposal.  “We’re nowhere near comprehensive disclosure,” Coukell said, “and if you do it company by company the information is not that useable.”

Harvard researcher Eric Campbell concurred, telling Modern Healthcare that when it comes to disclosure, details matter. “The real question is the level and depth of disclosure,” Campbell said, adding that penalties for non-compliance must be significant enough to encourage companies to collect and report the information.

For more about the Physician Payments Sunshine provisions, check out the RxP Sunshine Guide.

–Kate Petersen, PostScript blogger

In this week’s New England Journal of Medicine (subscription required), the office of the Inspector General of Health and Human Services suggests that pooled industry funding for Continuing Medical Education could provide a midterm solution to what the Inspectors hope will be the medical profession’s ultimate decision, to “eschew commercial support for CME.”

Authors Lewis Morris and Julie Taitsman, both counsel to the HHS OIG, ask “what is the best way to ensure that CME serves a bona fide educational purpose, is not co-opted as a marketing tool, and does not violate laws against fraud and abuse?” Their suggestion: a pooled-funding mechanism, whereby drug and device companies would contribute to unrestricted pools of funding controlled by independent grant organizations, who, through a transparent and unbiased process, would “award funding based on the educational merit of the CME programs, without allowing the donors to specify which programs their donations will fund.”

Of course, the authors admit that early signs suggest this is a hard sell to pharmaceutical and medical device companies, whose support for CME has grown 300 percent, and who currently develop and tailor their CME programming to align closely with their product marketing interests. An attempt by the American Academy of Orthopedic Surgeons to create such an independent pool won little company interest.

Still, the authors write, shoring up the independence of CME should be a top concern to the medical profession. “Since the marketing goals of pharmaceutical and device companies can influence CME funding,” they write, “preservation of the academic integrity of CME requires clear boundaries separating education and marketing.”

The HHS Inspector’s office has expressed concern before about the influence of commercial CME funding, and testified in July before a Senate committee on the commercial influence of CME on prescribing and medical practice.

Though the fall of Sen. Byron Dorgan’s drug re-importation bill in the health reform debate earlier this week isn’t news, yesterday’s NPR health blog “Shots” pointed to an analysis of pharma contributions and votes on the re-importation bill by Maplight, a national watchdog group that uses technology to highlight the relationship between financial support and political action. According to the NPR health blog, the Senators “voting nay have averaged 66 percent more in campaign contributions from Big Pharma than senators who voted yea.” Legalizing drug re-importation, which is illegal in the U.S. now, would lower drug costs dramatically – Dorgan estimated $100 billion in consumer savings over the next decade.

Despite the political drama around President Obama’s reversal on the issue of re-importation (he and some Democratic senators took high-visibility stands against the amendment this week, citing issues of drug safety), we hope the commitment the President and these Senators demonstrated to preventing unsafe products from reaching U.S. patients will extend to all the drugs, devices, and ingredients we currently legally import, many coming from countries such as India and China, where regulatory scrutiny is low.

PostScript takes a holiday

Happy tidings, and we’ll see you in 2010!

According to the New York Times, the deal PhRMA struck with the White House and Senate Finance committee this summer in exchange for its support of health reform is now apparently holding up a vote that would allow drugs to be reimported from Canada. The bill, sponsored by North Dakota Sen. Byron Dorgan, has enough votes to make it into the health reform bill. The CBO has said that the bill could save the U.S. $19.4 billion over the next 10 years, though industry and the FDA have voiced concerns that reimported drugs might be susceptible to adulteration.

But Sen. Dorgan says that his bill addresses those concerns.

“U.S. consumers are charged the highest prices in the world for drugs that sell for a fraction of the price in most other countries,” Mr. Dorgan said. “My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk. It applies only to F.D.A.-approved prescription drugs produced in F.D.A.-approved plants from countries with comparable safety standards.”

And two Senators have filed an amendment to the health reform legislation moving through Congress that would prevent drug companies from mining prescriber-identifiable data for marketing purposes, according to the Associated Press. Companies buy physician prescribing data and sell it to pharmaceutical companies, which use it to target their sales pitches. By filing the amendment, sponsors Sens. Kohl (D-WI) and Durbin (D-IL) have raised the national profile of this problematic marketing tactic, which some states have been grappling with for years.

“I think at both  federal and state levels you’ll see continued momentum because it’s clear the issue of drug marketing influence hasn’t been addressed yet,” Community Catalyst’s Marcia Hams told the AP.

In other Senate news, Big Pharma’s epistolary thorn-in-side Sen. Grassley was at it again this week, writing to 33 patient and professional medical groups to ask for details about the industry funding they receive.  Among them, the American Medical Association, the American Cancer Society, and the American Academy of Family Physicians.

Apparently, it’s all how you define industry. AMA spokesman Mike Lynch told the Times that “industry funding comprised less than 2 percent of the organization’s budget,” though last year the organization made a handy $47.6 million licensing physicians’ data, which is then bought by  pharmaceutical companies for data-mining.

“These organizations have a lot of influence over public policy, and people rely on their leadership,” Mr. Grassley told the Times. “There’s a strong case for disclosure and the accountability that results.”

And the St. Louis Post-Dispatch reported earlier this week on how Congress, FDA and consumer groups are looking at ways to curb TV and online direct-to-consumer advertising for patient safety.  Some members of Congress are considering putting a moratorium on ads for new drugs, or lifting the tax break pharma companies currently get on consumer ads. And recently, the FDA requested public comment on how to regulate pharma and medical device companies’ online marketing. At the hearing, the Pew Prescription Project’s Allan Coukell told agency officials that marketing regulations should protect the public health first, and not be loosened for online ads before there is evidence that the public health is being protected by such ads.

“Before the FDA provides a pathway for companies to do a whole new kind of marketing,” he told the Post-Dispatch,” I think they should be looking for evidence of health benefits,” he said.

–by Kate Petersen, PostScript blogger